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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K962255
Device Name CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
Applicant
Clarus Medical Systems, Inc.
1000 Boone Ave. N.
#100
Minneapolis,  MN  55427 -8656
Applicant Contact JOHN VANDEN HOEK
Correspondent
Clarus Medical Systems, Inc.
1000 Boone Ave. N.
#100
Minneapolis,  MN  55427 -8656
Correspondent Contact JOHN VANDEN HOEK
Regulation Number874.4760
Classification Product Code
EOB  
Date Received06/12/1996
Decision Date 09/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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